Health

Burzynski Research Institute, Inc. Announces Lifting of the FDA Partial Clinical Hold – Phase 3 Clinical Study Agreed Upon PR Newswire HOUSTON, June 23, 2014 HOUSTON , June 23, 2014 /PRNewswire/ — The Burzynski Research Institute, Inc. […]

Agreement on Phase 3 Trial Protocol of OSE Pharma’s OSE-2101 From the FDA and EMA PR Newswire PARIS, June 23, 2014 PARIS , June 23, 2014 /PRNewswire/ — OSE Pharma SA receives a positive agreement to initiate a Phase 3 clinical trial with OSE-2101, a therapeutic cancer vaccine for non-small cell lung cancer (NSCLC) OSE Pharma SA, a European cancer immunotherapy company with a specific T cytotoxic technology, today announced that it has received positive feedback from an end of Phase 2 / Pre-Phase 3 meeting with the U.S. Food and Drug Administration (FDA) and Scientific Advice from the European Medicines Agency’s (EMA). […]

CollPlant Holds Intellectual Property Rights in USA – One of the Largest Target Markets for the Company’s Products: US Patent Office Approves Patent for Company’s Collagen Production Techniques Yehiel Tal: “Approval for the patent will protect our position for many years as the only company in the world that is capable of producing human collagen from plants” PR Newswire REHOVOT, Israel, June 23, 2014 REHOVOT, Israel , June 23, 2014 /PRNewswire/ — CollPlant (TASE: CLPT), a developer and manufacturer of human collagen-based medical products announces, announce that the US Patent Office has approved its patent for processing methods for human collagen from plants. This buys CollPlant a competitive and commercial advantage that increases the potential economic value of its products before commencing marketing in the USA . Yehiel Tal , CEO of Collagen: “The USA is one of the Company’s strategic target markets, and we see the strengthening of our intellectual property in this territory as a significant achievement […]

FDA Takes Innovation-Friendly Approach to Regulating mHealth Developer PR Newswire GRAND RAPIDS, Mich., June 20, 2014 GRAND RAPIDS, Mich. , June 20, 2014 /PRNewswire/ — Ideomed, Inc ., a Michigan -based developer of mobile health solutions, recently received word from the Food & Drug Administration (FDA) that its mobile health app Abriiz meets the definition of a “medical device” for which the FDA intends to exercise “Enforcement Discretion.” This designation identifies mobile medical devices that “are not subject to further FDA regulatory requirements at this time.” This news clears the way for Abriiz to be connected to other FDA-regulated devices including blood glucose monitors, pulse oximeters, scales and blood pressure cuffs. […]

WuXi PharmaTech Toxicology Facility in Suzhou Passes FDA Inspection PR Newswire SHANGHAI, June 20, 2014 SHANGHAI , June 20, 2014 /PRNewswire/ — WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading pharmaceutical, biotechnology, and medical device R&D services company with operations in China and the United States , today announced that its toxicology facility in Suzhou recently passed a surveillance Good Laboratory Practice (GLP) inspection by the U.S. Food and Drug Administration (FDA) with no major observations. […]

MiMedx Expects To File Its First Investigational New Drug Application In July Company Adds Key Executives to Support its IND and BLA Initiatives PR Newswire MARIETTA, Ga., June 19, 2014 MARIETTA, Ga. , June 19, 2014 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG) , an integrated developer, processor and marketer of patent-protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today it expects to file its first Investigational New Drug (“IND”) application with the Food and Drug Administration (“FDA”) during the month of July 2014 […]

Novo Nordisk Announces U.S. Launch of New Insulin Device Levemir FlexTouch Latest delivery device advancement in the basal insulin category PR Newswire PLAINSBORO, N.J., June 19, 2014 PLAINSBORO, N.J. […]

Neurim Pharmaceuticals Announces Publication of Positive Effects of Add-on Circadin in Alzheimer’s Disease Patients PR Newswire TEL-AVIV, Israel, June 19, 2014 TEL-AVIV, Israel , June 19, 2014 /PRNewswire/ — Neurim Pharmaceuticals announced today publication of the results from an exploratory Phase 2 randomized placebo-controlled clinical trial evaluating the safety and efficacy of add-on Circadin (Prolonged Release melatonin 2mg) to standard therapy in Alzheimer’s disease (AD) patients. The study, published in the Clinical Interventions in Aging Journal, demonstrates positive effects of the drug on cognitive performance and sleep maintenance in the AD patients. “Endogenous melatonin levels are reduced already at preclinical AD stages. […]

QIAGEN Receives FDA Approval of artus CMV RGQ MDx Kit to Monitor Cytomegalovirus (CMV) Viral Load in Organ Transplant Patients PR Newswire GERMANTOWN, Maryland, and HILDEN, Germany, June 18, 2014 GERMANTOWN, Maryland , and HILDEN, Germany , June 18, 2014 /PRNewswire/ — Assay offers faster quantification of CMV DNA levels in patient samples Up to 60% of all transplant patients are repeatedly tested for CMV viral load to help avoid potentially life-threatening conditions caused by this virus PMA approval of artus CMV RGQ MDx Kit adds further value to the QIAsymphony modular family of automated instruments as the sixth approval or clearance in a growing menu of test content QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that its artus CMV RGQ MDx Kit for human cytomegalovirus (CMV) has been approved by the U.S. Food and Drug Administration (FDA) under a full premarket approval (PMA) […]

IGI Laboratories, Inc. Announces Sixteenth ANDA Submission PR Newswire BUENA, N.J., June 18, 2014 BUENA, N.J. , June 18, 2014 /PRNewswire/ — IGI Laboratories, Inc […]

Mirati Therapeutics Receives Orphan Drug Designation from U.S. Food & Drug Administration for Mocetinostat in Myelodysplastic Syndrome PR Newswire SAN DIEGO, June 17, 2014 SAN DIEGO , June 17, 2014 /PRNewswire/ — Mirati Therapeutics, Inc. […]

Valeant Pharmaceuticals Receives U.S. FDA Clearance For Restylane Silk PR Newswire LAVAL, Quebec, June 16, 2014 LAVAL, Quebec , June 16, 2014 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) today announced that that the U.S. […]

Alere Receives FDA Clearance for Alere™ i Influenza A and B Test First-ever Platform to Deliver Highly Accurate, Molecular Results in Under 15 Minutes PR Newswire WALTHAM, Mass., June 16, 2014 WALTHAM, Mass. , June 16, 2014 /PRNewswire/ — Alere Inc. […]

Sequenom, Inc. Receives U.S. […]

Novartis Holly Springs facility becomes first US pandemic-ready site licensed by the FDA to produce cell-culture influenza vaccines Cell-culture technology is a modern alternative to manufacture influenza vaccines without chicken eggs, with potential to rapidly respond to a pandemic[1] Flucelvax, an FDA-approved antibiotic- and preservative-free seasonal flu vaccine, will be manufactured at this site for the US market[2] Licensure marks milestone in Novartis’ public-private partnership to improve US capabilities to respond to seasonal epidemics and emerging public health threats PR Newswire BASEL, Switzerland, June 16, 2014 BASEL, Switzerland , June 16, 2014 /PRNewswire/ — Novartis today announced that the US Food and Drug Administration (FDA) licensed its manufacturing facility in Holly Springs, N.C. for the production of cell-culture influenza vaccines. This is the first US facility of its kind and is now approved for commercial production […]

Expanding Orthopedics Inc. Granted a Chinese Patent for its Unique Expandable XPED™ Pedicle Screw System The XPED™ expandable Pedicle Screw System was granted a Chinese patent, the sixth granted patent for Expanding Orthopedics in China PR Newswire OR-AKIVA, Israel, June 16, 2014 OR-AKIVA, Israel , June 16, 2014 /PRNewswire/ — Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, is pleased to announce the grant of a Chinese patent for its XPED™ System, the unique expandable pedicle screw and related instrumentation […]

Convergence Pharmaceuticals’ Novel Sodium Channel Blocker CNV1014802 Shows Excellent Efficacy and Safety in Ground-breaking Phase II Trigeminal Neuralgia Study PR Newswire CAMBRIDGE, England, June 16, 2014 CAMBRIDGE, England , June 16, 2014 /PRNewswire/ — Convergence Pharmaceuticals (“Convergence” or “the Company”) Highlights of the data: CNV1014802 was associated with a consistent reduction of pain severity and number of paroxysms in all primary and secondary outcomes 2.3 unit reduction in numeric rating scale (NRS) of pain intensity compared to placebo 55% decrease in pain severity vs 18% for placebo 60% average reduction in number of paroxysms compared to 12% in the placebo group Convergence Pharmaceuticals Holdings Limited (“Convergence”), the company focused on the development of novel and high value analgesic medicines for the treatment of chronic pain via a genetically defined approach, today announces positive data from the Phase II clinical trial of novel sodium channel blocker CNV1014802 in patients with trigeminal neuralgia (TGN), a very severe form of facial pain. CNV1014802 is a novel small molecule state-dependent sodium channel blocker that exhibits potency and selectivity against the Nav1.7 sodium channel. […]

Breckenridge Announces Approval for Duloxetine Delayed-release Capsules PR Newswire BOCA RATON, Fla., June 12, 2014 BOCA RATON, Fla. , June 12, 2014 /PRNewswire/ — Breckenridge Pharmaceutical, Inc. […]

iHealth Launches World’s Most Portable Mobile Blood Glucose Monitor Announces Simple Savings Program to Make Test Strip Replacement Convenient and Affordable, Essentially Eliminating the Need for Insurance Reimbursement PR Newswire MOUNTAIN VIEW, Calif., June 12, 2014 MOUNTAIN VIEW, Calif. , June 12, 2014 /PRNewswire/ — Today, iHealth Lab Inc. […]

Shire Agrees to FDA Request to Conduct Clinical Trials Investigating the Potential Use of Vyvanse (lisdexamfetamine dimesylate) in Preschool-Age Children with ADHD PR Newswire LEXINGTON, Massachusetts, June 12, 2014 LEXINGTON, Massachusetts , June 12, 2014 /PRNewswire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that it has agreed to a Written Request by the Food and Drug Administration (FDA) to conduct pediatric clinical studies to investigate the potential use of Vyvanse (lisdexamfetamine dimesylate) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age children, ages 4 to 5. “Shire is committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients,” said Philip Vickers , Ph.D., Head of Research and Development at Shire. […]